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An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys. Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jaeb Center for Health Research
Tampa, Florida, United States
Start Date
June 20, 2023
Primary Completion Date
September 8, 2023
Completion Date
September 8, 2023
Last Updated
October 12, 2023
8
ACTUAL participants
Community-Derived Open-Source Automated Insulin Delivery Loop System
DEVICE
Lead Sponsor
Jaeb Center for Health Research
Collaborators
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062